Case Studies of IPV Introduction: Albania, Nigeria, and Tunisia ACKNOWLEDGEMENTS

This document is the result of the thinking, collaboration, and hard work of many people. We would like to thank the following group of individuals who played an instrumental role in the writing and review of this document:

LEAD AUTHORS Lauren Platt, Katie Gorham, and Lois Privor-Dumm

ALBANIA CASE STUDY Silvia Bino, Erida Nelaj, and Iria Preza

NIGERIA CASE STUDY Chisom Obi, Shola Molemodile, Ifeyinwa Okoro, Tina Obande, and Chizoba Wonodi

TUNISIA CASE STUDY Anne-Marie Giangiulio, Ramzi Ouhichi, Kamal Fahmy, and Essia Ben Farhat Hmida

We would also like to thank the numerous people who graciously gave their time to be interviewed for this work and those that helped coordinate the case study, including:

ALBANIA Albana Ahmeti, Gazmend Bejtja, Silvia Bino, Evgjeni Kaci, Eduard Kakarriqi, Georgina Kuli-Lito, Erida Nelaj, Iria Preza, and Klodjan Rjepaj

NIGERIA Emmanuel Abanida, Toye Abolade, Mallam Bakoji Ahmed, Maryam Ali, Misbau Lawan Didi, Obi Ezebilo, Samuel Jiya, Gideon Kuje, Mustapha Mahmud, Pascal Mkanda, Adamu Nuhu, Abiola Ojumu , Bassey Okposen, Faisal Shuaib, Abdullahi Suleiman, and Salome S. Tor

TUNISIA Meha Bergaoui, Nesrine Boujenoui, Abdelkrim Brini, Leila Diffallah, Essia Ben Farhat Hmida, , Ramzi Ouhichi, Nabil Ben Salah, Mme. Sihem, and Mahrez Yahyaoui

Funding for this document was provided by Task Force for Global Health through the support of the Bill and Melinda Gates Foundation. TABLE OF CONTENTS

Acknowledgements...... 2 Executive Summary...... 4 Introduction...... 5 The Path to Polio Eradication...... 5 Bringing In Every Possible Tool...... 5 Unprecedented Pace for IPV Introduction...... 6 Progress...... 6 Albania...... 7 Introduction...... 8 Decision-Making...... 8 Pre-Introduction Activities...... 9 Implementation...... 10 Lessons Learned...... 10 Timeline...... 11 Nigeria...... 12 Introduction...... 13 Decision-Making...... 13 Pre-Introduction Activities...... 14 Implementation...... 16 Lessons Learned...... 16 Timeline...... 17 Tunisia...... 18 Introduction...... 19 Decision-Making...... 19 Pre-Introduction Activities...... 20 Implementation...... 20 Lessons Learned...... 20 Timeline...... 22

International Vaccine Access Center (IVAC) • Johns Hopkins Bloomberg School of Public Health | 3 EXECUTIVE SUMMARY

Since its launch at the 44th World Health Assembly in 1988, the Albania, Nigeria, and Tunisia. Each case study describes the Global Polio Eradication Initiative (GPEI) has reduced the global decision-making process, the pre-introduction activities that incidence of polio by more than 99% and the number of countries were conducted, and the implementation process for each with endemic polio from 125 to 3. While this progress is immense, a country. Each case study concludes with a synthesis of the great deal of work is still required for full eradication of the disease. lessons learned during IPV introduction that can be applied to other countries. Using the lessons learned from Albania, Nigeria, There are two vaccines used to prevent polio: (1) the oral Polio and Tunisia—both their successes and their challenges— vaccine (OPV) and (2) the inactivated polio vaccine (IPV). OPV other countries have the opportunity to take advantage of the is extremely safe and effective at protecting children against strategies which were most effective and avoid common pitfalls. lifelong paralysis caused by the poliovirus. Over the past ten years, more than 10 billion doses of OPV have been given to Many of the findings from these case studies are programmatic nearly three billion children worldwide. More than 10 million and therefore applicable to not only IPV but also to the cases of polio have been prevented, and the disease has been introduction of other vaccines. reduced by more than 99%. It is the appropriate vaccine through which to achieve global polio eradication. However, OPV Albania, Nigeria, and Tunisia were selected because they are contains attenuated (weakened) polioviruses. On extremely rare geographically and economically diverse. Nigeria, is located in occasions, the use of OPV can result in paralysis due to vaccine- Africa and is eligible for financial support from Gavi, the Vaccine associated paralytic polio (VAPP) and circulating vaccine-derived Alliance. Albania is located in Europe and is an upper-middle polioviruses (cVDPVs). For this reason, the global eradication income country that was Gavi-eligible until 2013. Finally, Tunisia of polio requires the cessation of all OPV use in routine is located in the Eastern Mediterranean and is an upper-middle immunization (RI), as soon as possible after the eradication income country. Unlike Albania, Tunisia has never been Gavi- of wild poliovirus (WPV) transmission. This will leave only IPV eligible and has always self-financed all vaccine introductions. in widespread use, which eliminates the chance of VAPP cases and the circulation of cVCPVs (IPV does not cause these), By comparing and contrasting this diverse set of countries for allowing for complete eradication of all polioviruses in the world. this case study, it is possible to illustrate some of the similarities and differences between countries related to these factors. At the end of 2012, global immunization experts made a landmark recommendation that every country in the world Reasons for success seen across countries exclusively using the oral polio vaccine (OPV) should add • IPV was best accepted by caregivers in countries where there at least one dose of the inactivated polio vaccine (IPV) to was a history of public trust in the immunization program. their national immunization schedule by the end of 2015. • Strong, clear and simple messages are the most effective The primary role of introducing one dose of IPV into routine for caregivers. In some countries, the most effective immunization programs is to mitigate risks associated with messages did not specifically mention polio, IPV, or OPV. OPV withdrawal and possible reintroduction of polioviruses. The messages simply stated that a new vaccine was being introduced to improve the immunization schedule. This recommendation for global IPV introduction means • Many middle-income countries use data to customize that 126 countries must change their national immunization global vaccine recommendations to their needs. schedule within the short timeframe of three years. Cross-cutting challenges Since January 2013, these countries have been making • It was difficult to revise and disseminate all immunization the necessary plans to introduce IPV by year-end 2015. As materials given the condensed timeline. of August 2015, 29 out of the 126 countries that need to • There was confusion about eligibility in some countries, which introduce have done so.1 led to vaccination of children outside of the target age range. • Many countries experienced a delay when planning for As countries prepare to introduce IPV, there is an opportunity IPV introduction. In some cases, the delay was short (2 to leverage lessons learned from countries that have already months) while in other cases the delay was much longer. introduced the vaccine. The purpose of this document is to give an in-depth overview of IPV introduction in three countries: Documenting vaccine introductions and case studies is a crucial part of the improvement process. Given the large

1 IPV/bOPV Implementation Working Group Implementation Call Report number of countries about to introduce IPV, there is a unique August 11, 2015 opportunity to put this learning immediately into practice.

4 | Case Studies of IPV Introductions: Albania, Nigeria, and Tunisia • 2015 INTRODUCTION

THE PATH TO POLIO ERADICATION only be given by a trained healthcare worker, and it is more expensive (between $1-4 per dose) than OPV. Because of Polio is a devastating, debilitating, and deadly disease; one of the advantages of OPV, it has been used in low- and middle- the largest social movements in human history – the Global income countries where the risk of large polio outbreaks was Polio Eradication Initiative (GPEI) – aims to make polio a the greatest. memory. GPEI is a public-private partnership established in 1988 to eradicate polio worldwide. It is a collaboration of However, following the significant progress towards polio national governments and multiple international organizations eradication, in 2012, the Strategic Advisory Group of Experts including the World Health Organization (WHO), Rotary on Immunization (a group of immunization experts which International, the US Centers for Disease Control and advise the World Health Organization on all matters related Prevention (CDC), and the United Nations Children’s Fund to immunization) recommended that every country in the (UNICEF). The goal of the GPEI is to completely eliminate world using only OPV should add at least one dose of IPV polio so that no child will ever be paralyzed by polio again. to the immunization schedule by the end of 2015. The rationale was that children that receive both vaccines have When the GPEI was created in 1988, polio was causing the best possible protection because there are important outbreaks around the world, and an estimated 350,000 benefits from both vaccines. Additionally, the Global Polio children were being paralyzed by the poliovirus every year. Eradication Initiative recognized that because in extremely Over the past 30 years, the number of annual polio cases has rare cases OPV can mutate into a poliovirus that causes been reduced by more than 99%. In 2014, there were only paralysis, eliminating all paralytic polio disease would 359 cases of polio reported in three countries: Afghanistan, Nigeria, and Pakistan. The world is closer than ever to eradicating polio permanently, but as long as wild poliovirus is allowed to paralyze children the job is not done. ...The World Health Organization... BRINGING IN EVERY POSSIBLE TOOL recommended that every country There are two different vaccines used to vaccinate against polio: the Oral Polio Vaccine (OPV) and the Inactivated Polio Vaccine (IPV). For many years, OPV was the main tool used in the world using only OPV should by the GPEI to eradicate polio. OPV has been used as the primary vaccine for the polio program because: (1) it provides add at least one dose of IPV to the good immunity after 3-4 doses, (2) it helps stop transmission of the virus by limiting its ability to replicate in the gut, (3) it is an oral, droplet vaccine that does not require a trained immunization schedule by health worker to administer, and (4) it is inexpensive (less than $0.15 per dose). One disadvantage of OPV is that in the end of 2015. extremely rare circumstances the vaccine virus can mutate and cause polio. This is called vaccine-associated paralytic polio (VAPP) and happens in approximately 1 in 2-4 million children after receiving OPV. Furthermore, in even rarer ultimately require completely stopping the use of OPV circumstances, the virus can mutate to the point that it is globally (once wild poliovirus is eradicated). It would need to again able to cause paralytic polio and even polio outbreaks; come in phases – first switching from tri-valent OPV (tOPV), these viruses are called circulating vaccine-derived which contains all three types of polio, to a bi-valent OPV polioviruses or cVDPVs. (bOPV) which does not contain type 2 poliovirus, which has been eradicated and no wild case seen since 1999. It does, Because of these rare events, some countries use IPV to however cause 90% of cVDPVs and 40% of all VAPP cases. vaccinate against polio. The main advantages of IPV are The removal of type 2 will also improve immunity of the that: (1) it provides very strong immunity after only 1-2 remaining two serotypes, 1 and 3. Introducing IPV globally doses, and (2) it cannot mutate to cause polio. But IPV became an important first step towards stopping the use of does not stop replication in the gut as well as OPV and can OPV globally and provides protection against all three types lead to more transmission, it is an injectable vaccine, can of polio.

International Vaccine Access Center (IVAC) • Johns Hopkins Bloomberg School of Public Health | 5 When the landmark recommendation to introduce IPV said ‘Really? We are going to do this? Are you mad?’” in every country was made, there were 126 countries in National immunization programs were also surprised by the world that were only using OPV. This meant that 126 the recommendation. As explained by Michel Zaffran, countries around the world had to change their national coordinator of the Expanded Program for Immunization immunization schedule within the short timeframe of three at the World Health Organization: “It was sort of seen by years. everyone that heard that recommendation as something impossible to achieve... When [the timeline for IPV UNPRECEDENTED PACE FOR IPV INTRODUCTION introduction] was first presented to countries it was received with a lot of skepticism. Another sort of global When the plan to introduce IPV in 126 countries in only goal set by the international community that doesn’t really 3 years was announced, it came as a shock to many in take into account the difficulty that countries are facing.” the immunization community. Given the historically slow pace of vaccine introductions, many people thought it PROGRESS would be impossible. As describe by Helen Rees, chair of the SAGE committee that made the recommendation, Despite the skepticism from the global community, to date, “I think when we heard the pace that the colleagues 125 out of 126 countries (>99%) have formally committed to who are driving the eradication program put to [us], introducing IPV by the end of 2015. As of August, 2015, 29 we were all astonished. We all raised our eyebrows and out of the 126 countries have introduced IPV.

Pace of IPV introductions compared with the historical pace of other vaccine introductions:

6 | Case Studies of IPV Introductions: Albania, Nigeria, and Tunisia • 2015 ALBANIA ALBANIA

INTRODUCTION national immunization program as PCV is relatively expensive when compared to other vaccines. Albania is a country located in Southeast Europe, and it borders Montenegro, Kosovo, Macedonia, Greece, and the Albania has launched several initiatives in the past decade Mediterranean Sea. It has an estimated population of about to strengthen vaccine delivery and operations. This includes 2.8 million and an annual birth cohort of approximately the introduction of an electronic Immunization Information 35,760.2,3 Albania is classified by the World Bank as an System (IIS) and an overhaul of cold chain equipment. upper-middle income country.4 The IIS was successfully piloted in one district and is now being scaled up nationwide. Additionally, many cold chain Albania has a strong immunization program, with routine equipment units were replaced, and since 2013, all cold immunization coverage estimated to be 99% for the third chain units in the country are pre-qualified. dose of the Diphtheria-Tetanus-Pertussis containing vaccine (DTP3).5 In addition to having high immunization coverage, Vaccine introductions in Albania: Albania has also introduced six new vaccines into the routine immunization program over the past 15 years. Year Vaccine Financing 2000 Rubella (as MR) UNICEF, Govt In 2000, Albania added the rubella vaccine to the national 2000 Hepatitis B Gavi until 2006 2005 Mumps (as MMR) Govt immunization program by replacing their measles vaccine 2008 Hib (as Penta) Gavi until 2013 with the Measles-Rubella (MR) vaccine. The introduction of 2011 PCV Govt the MR vaccine was financed by UNICEF, the Government 2014 IPV Govt of Albania, and other partners. In 2000, the Government of Albania partnered with Gavi, the Vaccine Alliance, to Endemic wild poliovirus transmission was interrupted in finance the introduction of a standalone Hepatitis B (HepB) Albania in 1985. However, in 1996, a large outbreak of polio vaccine. The HepB vaccine was paid for by Gavi until 2006, occurred following importation of the virus from another at which point the government took responsibility for the total country. During the outbreak, the majority of cases were cost of all HepB vaccinations. In 2005, Albania added the among 10-34 year olds. Poor cold chain maintenance and Mumps vaccine to the national immunization program by decreased coverage in the 1990s during political transition replacing the MR vaccine with the Measles-Mumps-Rubella were thought to be the main reasons for the large pocket (MMR) vaccine. The introduction of the MMR vaccine of susceptible individuals. The outbreak was stopped in was completely financed by the Government of Albania. December 1996 following two national immunization days. In In 2008, Albania partnered with Gavi again to introduce total, the outbreak resulted in 138 cases of paralysis and 16 the Haemophilus influenzae type b vaccine (Hib). Hib was deaths. No cases of wild poliovirus have been detected since introduced by replacing the DTP vaccine and the HepB 1997. But, the legacy of this outbreak has resulted in strong vaccine with a combination pentavalent vaccine. Although and sustained commitment to polio eradication in Albania. this vaccine was initially introduced with the financial support of Gavi, since mid-2013 the Government of Albania has In 1989, a large measles outbreak affecting all age groups and taken responsibility for the total cost of the pentavalent continued circulation of the measles virus pushed the country vaccine. In 2011, the Government of Albania self-financed to increased efforts on measles and rubella elimination. No the introduction of the 10-valent pneumococcal conjugate measles cases have been documented in Albania since 2007. vaccine (PCV-10). This was a significant achievement for the DECISION-MAKING

2 CENSUS 2011, Government of Albania. Available at: http://www.instat. Immunization experts in Albania discussed the pros and cons gov.al/al/census/census-2011/t%C3%AB-dh%C3%ABnat-e-census-2011. of introducing IPV for many years. In Albania, the discussion aspx surrounding IPV introduction pre-dated the SAGE global 3 Government of Albania, INSTAT. Available at: http://www.instat.gov.al/al/ recommendation to introduce IPV in 2012. themes/popullsia.aspx 4 World Bank, country and lending groups, 2014 revision. Updated annually in July. Available at: http://data.worldbank.org/about/ The main reasons that Albania considered introducing country-and-lending-groups IPV was a desire to: (1) harmonize the Albanian national 5 WHO-UNICEF estimates of DTP3 coverage, 2014 revision. Updated annu- immunization schedule with other European countries and ally in July and available at: http://apps.who.int/immunization_monitoring/ globalsummary/timeseries/tswucoveragedtp3.html (2) eliminate vaccine-associated paralytic polio (VAPP).

8 | Case Studies of IPV Introductions: Albania, Nigeria, and Tunisia • 2015 In Albania, whenever a new vaccine is being considered for seroconversion against type 2 polioviruses, Albania decided introduction, an evidence-based analysis is conducted to to introduce two doses of IPV. It was then decided that the determine whether or not the evidence supports the vaccine doses would be given at 2 months (replacing the first OPV introduction. In the analysis, the value of introducing the vaccine dose) and 4 months (replacing the second OPV dose). is evaluated using a standard set of criteria including the Children would then receive a dose of OPV at 6 months (no disease burden, other prevention and control measures, cost- dose of IPV would be given at 6 months). By using two doses effectiveness, alignment with global recommendations, vaccine of IPV at the first two immunization contacts, VAPP would be supply, etc. The findings are then presented to the members of eliminated and type 2 immunity would still be high. the Interagency Coordinating Committee (ICC) who make the final decision on whether or not to recommend the vaccine. The next step was to decide which IPV product should be introduced. The three options being considered were: (1) For the introduction of IPV, the national immunization introduce a standalone IPV to the schedule, (2) switch from program followed the standard protocol and developed an the current pentavalent vaccine (DTwP-HepB-Hib) to a evidence-based analysis of IPV introduction. Because Albania pentavalent vaccine that contained IPV (DTaP-Hib-IPV) and had discussed IPV introduction for many years, the analysis introduce a Hepatitis B standalone vaccine, or (3) introduce had already been mostly drafted, the national immunization a hexavalent vaccine (DTaP-HepB-Hib-IPV). In order to make program was able to rapidly finalize the IPV analysis and this decision, the National Immunization Program prepared present it to the ICC for immediate consideration. an analysis of the advantages and disadvantages of each presentation and presented it to the Ministry of Health and the Following the SAGE recommendation to introduce IPV Ministry of Finance. The main advantage of the hexavalent (as well as the additional recommendation to switch from vaccine was that children would receive fewer injections per tri-valent OPV (tOPV) to bi-valent OPV (bOPV) to reduce immunization visit; the disadvantage of the hexavalent vaccine risk of VAPP and circulating vaccine-derived poliovirus was that it was significantly more expensive than the other (cVDPV) while increasing immunogenicity of types 1 and 3), products. The main advantage of the pentavalent vaccine the topic was raised at the ICC meeting in February 2013, containing IPV (DTaP-Hib-IPV) was that it was cheaper than and the ICC recommended that IPV be introduced into the the hexavalent vaccine; the disadvantage of this vaccine is that routine immunization program. Because Albania had been it was more expensive than the DTwP-HepB-Hib pentavalent debating the introduction of IPV for many years, the SAGE vaccine currently used by the national immunization program. recommendation is not cited as the main reason for the Additionally, it is important to note that both the hexavalent national decision to introduce IPV in Albania. Rather, the and alternative pentavalent vaccines contain an acellular SAGE recommendation could be seen as one of the “triggers” pertussis component. Because many countries in Europe use which accelerated the introduction of IPV in Albania. a vaccine with an acellular pertussis component, Albania has discussed switching from a whole cell pertussis vaccine to an After the ICC recommended the eventual switch from OPV to acellular vaccine. However, the disadvantage of switching to IPV and the Ministry of Health made the decision to introduce an acellular vaccine is that the immunity from the acellular IPV into the routine program, the National Immunization vaccine wanes over time and multiple boosters are needed to Program (NIP) at Institute of Public Health had to make prevent pertussis outbreaks. After careful consideration, the three key technical decisions about IPV rollout: the number Government of Albania decided to introduce a standalone IPV of doses of IPV each child should receive, the age at which vaccine. The main driving factor for this decision was the lower children should receive each IPV dose(s), and which IPV cost of the vaccine. product should be introduced (standalone IPV, pentavalent containing IPV, or hexavalent). It is important to note that at the time the ICC discussed IPV introduction, rotavirus vaccine was also being considered for When deciding on the number and timing of the IPV doses, introduction. However, it was decided to wait to introduce Albania prioritized the following key factors: (1) the new rotavirus vaccine, due to the cost. schedule should ensure high seroconversion against type 2 polioviruses after the switch from tOPV to bOPV, (2) the PRE-INTRODUCTION ACTIVITIES new schedule should decrease, if not eliminate completely, VAPP, (3) the new schedule should be similar to schedules in Following the decision to introduce IPV, the first step was neighboring European countries, and (4) if possible, the new to develop a comprehensive guide on IPV for healthcare schedule should minimize the number of injections a child professionals. The guide covered information on IPV safety, receives at each visit. immunity, and the rationale for introduction. These guides were then distributed to health facilities, and healthcare In order to minimize VAPP and simultaneously achieve high workers were trained on IPV introduction.

International Vaccine Access Center (IVAC) • Johns Hopkins Bloomberg School of Public Health | 9 Next, key messages were developed about IPV introduction. There is a history of strong political commitment to the The two key messages were: (1) “We are improving our immunization program in Albania. This commitment has been immunization schedule!” and (2) “Our schedule is now a central reason that Albania has successfully introduced comparable to the other European countries.” TV and radio numerous vaccines over the past decade. As eloquently stated spots were used to sensitize the public. by Klodjan Rjepaj, Deputy Minister for Health, “Immunization is one of the aspects that never failed in Albania. Even during 1997, Single dose vials of IPV were procured from the government when there was civil unrest and the government and the state budget through the UNICEF supply division. The handling failed to offer public services—immunization was still going on.” and stock management of IPV was the same as for all other Furthermore, Albania is always looking for ways to strengthen and vaccines. Because Albania had recently updated the cold improve their system: “Immunization is something which is very chain equipment across the country, no changes needed to important in Albania and it has been important for all times—even be made to the cold chain before IPV introduction. before 1990. So we didn’t start from scratch. We had a basis, and then we wanted to improve it.” Following the changes in the immunization schedule, instructions on how to use the new immunization cards were presented to Lesson 2—Public trust in the immunization system was the immunization healthcare professionals as part of the training foundational to the acceptance of IPV for the introduction of IPV. They were instructed that on the In addition to political commitment, there is also a strong immunization card of children born from 1 March 2014, OPV cultural commitment to immunization in Albania. As stated should be replaced with IPV at 2 and 4 months of age. by Silvia Bino, Director of Infectious Disease at the Institute of Public Health, “Vaccination is a kind of culture in Albania. IMPLEMENTATION This is something very important, and we want to keep it.” The public acceptance of IPV (and of vaccines in general) was Albania introduced IPV in 2014 as planned. The eligibility policy attributed to the public trust in the immunization system. This was that any child born from 1 March 2014 onwards would two is related to a historical acceptance of immunization, which doses of IPV at 2 and 4 months of age and one dose of OPV at 6 has been built over several decades. As explained by Klodjan months. Children born before 1 March 2014 were not eligible to Rjepaj, “Immunization has been a program that has been well- receive IPV. supported, well-accepted, and a program that Albanians trust.”

Preliminary findings suggest that the introduction of IPV has Lesson 3—A good recommendation from a healthcare gone very smoothly. An analysis of coverage data shows that professional was critical to caregiver acceptance of IPV there were no changes in immunization coverage before In Albania, multiple informants felt that the healthcare and after IPV introduction. There is also no evidence for an professionals played the most important role in ensuring increased number of refusals at the 2 and 4 month visits, acceptance of IPV among caregivers. As stated by Klodjan indicating that IPV is highly accepted among caregivers. Rjepaj, “I think it is crucial to understand that communication is not just media. It is training of our professionals in a When visiting some healthcare facilities, healthcare workers capitulary way so that they communicate with the parents were asked whether or not caregivers were okay with their in their area. It is that daily communication.” Furthermore, child receiving three injections in one visit. In most healthcare when caregivers were asked if they were hesitant to let their facilities, healthcare workers responded that caregivers had no child receive multiple injections, many caregivers responded problem allowing their child to receive three injections because that they receive whatever vaccines the healthcare worker it was recommended. In a few healthcare facilities, healthcare recommends. From the caregivers perspective, it didn’t workers indicated that if a caregiver is very hesitant to let their matter how many injections the child received (one, two, or child receive three injections in one visit, they give the child two three), but rather the most important thing was that the child shots (pentavalent and IPV) and then tell the mother she must got all recommended vaccinations. come back for PCV in one week. Although it is possible that this could affect coverage of PCV due to a missed opportunity, Lesson 4—Using date of birth to determine eligibility for IPV findings have found that almost all caregivers return within was easy and effective 1 week for the PCV visit. This is most likely due to the strong Unlike some countries, Albania used a date of birth cutoff cultural value placed on immunization in Albania. to determine if a child was eligible to receive IPV. The formal policy was that “all children born on or after 1 March 2014 are LESSONS LEARNED eligible to receive IPV.” In contrast, some other countries used an “age-at-visit” eligibility policy such as “all children older than Lesson 1—Strong political commitment to immunization made 14 weeks that come for immunization should receive IPV.” for the smooth introduction of IPV Using a Date of Birth cutoff proved to be a simple and easy to

10 | Case Studies of IPV Introductions: Albania, Nigeria, and Tunisia • 2015 enforce programmatically. As a result, very few children outside the central level which facilitates coverage monitoring. of the target age group received IPV. In contrast, in some of the countries that used “age at visit” to determine eligibility, Lesson 7—Taking advantage of the opportunity of a new healthcare workers vaccinated children outside of the target age vaccine introduction to make other changes to immunization group. Because each country’s supply is based on a calculated schedule was beneficial number of children eligible, in some countries the lack of clarity Albania used the opportunity of IPV introduction to make two on eligibility actually led to a national IPV shortage. other changes to the immunization schedule that the national immunization program had been planning on making. The two Lesson 5—It was not possible to revise, reprint, and distribute other changes made were (1) changing the PCV schedule to immunization cards by introduction date 2 plus 1 schedule and (2) changing the tetanus immunization It is important to note that because IPV was introduced in a policy. Thinking multiple years in advance and making multiple short timeline, there was not enough time to revise, reprint, and changes at once allows programs to use fewer resources and disseminate new vaccination cards and immunization records avoid having to conduct multiple trainings. to each health facility. Luckily, healthcare workers were able to adapt and manually write in IPV. However, it should be noted that Lesson 8—IPV might have impacted the introduction of manual writing in of additional vaccinations is not ideal. Writing in rotavirus vaccine vaccinations manually might lead to inaccuracies in documenting At the time when Albania recommended the introduction of which vaccines were given to each child and/or might mean a IPV, the country was also contemplating the introduction of healthcare worker is more likely to forget to administer a vaccine the rotavirus vaccine. At the time, the National Immunization because it was not written on the vaccination card as a reminder. Technical Advisory Group (NITAG) decided not to For this reason, the Albania immunization program is moving to recommend rotavirus vaccine for introduction. While it is an electronically based system. true that the decision to introduce IPV might have had some role is postponing the introduction of rotavirus vaccine, it is Lesson 6—Using an electronic Immunization Information difficult to determine the exact effect since the overall cost System (IIS) simplified many aspects of IPV introduction of rotavirus introduction ($8-9 per child) is 3 to 5 times more Albania has successfully piloted and implemented an expensive than IPV ($2.8 per child). electronic Immunization Information System, which is functioning in multiple health centers in one district. The ISS is Lesson 9—Clear, positive, and simple messaging to caregivers currently being scaled up and introduced nationwide. During is effective IPV introduction, multiple advantages of using an ISS during a Albania chose to emphasize two simple messages during vaccine introduction were demonstrated. The major benefits of IPV introduction: (1) “We are improving our immunization an electronic system were: (1) the IIS automatically calculates schedule!” and (2) “Our schedule is now comparable to the whether or not a child is eligible for IPV instead of relying other European countries.” These messages are concise, on healthcare workers to enforce an eligibility policy, (2) the clear, and easy to understand. Interestingly—neither of these immunization system can easily be updated to include a new messages mention IPV or polio. However, the messages cleverly vaccine and there is no need to revise, reprint, and distribute appeal to the public and send a positive message about the way immunization cards, and (3) the ISS delivers real-time data to IPV is improving the immunization program.

TIMELINE February 2013: ICC recommends switch from OPV to IPV

June 2013: Request to UNICEF to procure first 36,000 doses of IPV

September 2013: Forecast submitted to UNICEF for the year 2014 (two doses of IPV included for the whole year

March-April 2013: Comprehensive manual on IPV for healthcare professionals prepared

December 2013: Meeting with healthcare workers regarding the switch from OPV to IPV

March 2014: Reversion of immunization schedule (by introducing IPV)

April 2014: Retraining of health care workers on IPV and revised immunization schedule May 2014: Albania begins to administer two doses of IPV into routine immunization for children born from 1 March 2014 onwards Since June 2014: Ongoing evaluation of vaccine coverage quarterly and annually as done for the other existing vaccines included in the Albanian immunization schedule

International Vaccine Access Center (IVAC) • Johns Hopkins Bloomberg School of Public Health | 11 NIGERIA 12 | Case Studies of IPV Introductions: Albania, Nigeria, and Tunisia • 2015 NIGERIA

INTRODUCTION a lasting impact and some individuals are still skeptical of vaccine safety. Additionally, repeated rounds of door-to-door Nigeria is a West African country that borders Benin, Chad, immunization campaigns have led to healthcare worker fatigue Cameroon, Niger, and the Gulf of Guinea. It has an estimated in some areas. Similarly, caregivers who have had their child total population of 183.5 million and an annual birth cohort of vaccinated over 10 times are sometimes unconvinced of 7.4 million, making it the most populous country in Africa and the need for additional vaccinations. Terrorist activities have the seventh most populous country in the world.6 also negatively affected the polio eradication program in the northern part of the country. For instance, in February 2013, The WHO and UNICEF estimate the routine immunization nine female polio vaccinators were killed in two shootings at coverage for the third dose of the pentavalent vaccine health centers in a northern state. These factors contribute to (DTP-HepB-Hib) to be 66%.7 With regards to experience the ongoing sensitivity of polio eradication. introducing new vaccines, Nigeria introduced two vaccines into the routine immunization system in recent years: the DECISION-MAKING DTP-HepB-Hib pentavalent vaccine (penta) between 2012 and 2014 and the pneumococcal conjugate vaccine (PCV) in 2014. Following the World Health Organization’s (WHO) Strategic Advisory Group of Experts (SAGE) recommendation for IPV Nigeria is one of three remaining wild poliovirus endemic in November 2012, IPV introduction was discussed at the countries in the world, meaning the country has never WHO African Regional Committee of Health Ministers in interrupted transmission of wild-type virus. However, on July September 2013. This prompted high-level discussions about 24, 2015, Nigeria marked one year of no reported cases the introduction of IPV in Nigeria. of wild poliovirus.8 The absence of wild polio cases has led Vaccine introductions in Nigeria: to optimism that the country might have eradicated wild poliovirus completely. The country has one case in 2015 of Year Vaccine Financing circulating vaccine-derived poliovirus (cVDPV2) as of July 2012-2014 Hib (as Penta) Gavi 2015. Two more years must pass without a case of wild 2014 PCV Gavi poliovirus for Nigeria to be certified as polio-free, along with 2015 IPV Gavi the rest of WHO’s African region. 9 Because Nigeria is a polio endemic country, the rationale for the introduction of inactivated polio vaccine (IPV) in Nigeria Polio is a sensitive topic in Nigeria both culturally and was slightly different than the rationale for IPV introduction in politically. Political support for polio eradication from the most other countries. While in most countries, IPV is being central government in Nigeria is strong. However, there is introduced as a risk mitigation strategy to prevent cVDVP some local resistance (both political and cultural) to polio poliovirus outbreaks and cases of VAPP, in Nigeria, IPV is being eradication. In 2003, there was a boycott of polio vaccination introduced both as a risk mitigation strategy and as one of the in select northern states following rumors that the vaccine strategies to accelerate the eradication of wild poliovirus. was contaminated with anti-fertility agents, HIV, and carcinogens. Although the boycott has ended, there has been It was the responsibility of the Inter-agency Coordinating Committee (ICC)—the main decision-making body in 6 United Nations, Department of Economic and Social Affairs, Nigeria related to immunization policy and new vaccine Population Division (2013). World Population Prospects: The 2012 introductions—to decide whether or not IPV should be Revision, CD-ROM Edition. - See more at: http://www.gavi.org/country/ introduced into the routine immunization program of Nigeria. albania/#sthash.1APrPOiP.dpuf To make this decision, the ICC considered input from various 7 WHO-UNICEF estimates of DTP3 coverage, 2014 revision. Updated annu- 10 ally in July and available at: http://apps.who.int/immunization_monitoring/ stakeholders including the Core group , the Nigerian globalsummary/timeseries/tswucoveragedtp3.html Academy of Sciences, the Pediatric Association of Nigeria, 8 World Health Organization (WHO) (2014) Acute flaccid paralysis (AFP) traditional leaders, and religious leaders. surveillance data and polio case count. Available at: https://extranet.who. int/polis/public/CaseCount.aspx (accessed 6 June 2015). 9 Global Polio Eradication Initiative Available at: http://www.polioeradication. Identifying and securing financial resources to pay for a org/Infectedcountries/Nigeria.aspx (accessed 11 August 2015) vaccine is a key part of the decision-making process. In 10 The Core group is a coalition of technical stakeholders and includes most countries, vaccines that are recommended by the members from the following immunization partners: NPHCDA, WHO, government are provided free of charge to all children. UNICEF, BMGF, IVAC, CDC, CHAI, Rotary, and the members of the Partnership for Reviving Routine Immunization in Northern Nigeria, Therefore, any vaccine recommendation has significant Maternal Newborn and Child Health Initiative (PRRINN MNCH). implications for local and national governmental budgets.

International Vaccine Access Center (IVAC) • Johns Hopkins Bloomberg School of Public Health | 13 Prior to IPV introduction, Nigeria partnered with Gavi to PRE-INTRODUCTION ACTIVITIES introduce two new vaccines into the routine immunization system (penta and PCV) and to conduct vaccination Coordination campaigns against yellow fever, measles, and meningitis. Due The NVI task team coordinated all activities related to to recent economic growth, Nigeria is now considered by Gavi IPV introduction in Nigeria. The different phases of the to be preparing for transition from Gavi support. This means pre-introduction activities developed by the NVI task team that over the next few years Nigeria will incrementally take were reviewed by the Routine Immunization Working Group over all financial responsibility for vaccination. In a couple of (RIWG), then Core Group, and finally approved by ICC. years, once the country has graduated, Nigeria will no longer be eligible to receive any funding for vaccines from Gavi. Community Acceptibility Studies Due to history of polio immunization rejection in Nigeria and In November 2013, the Gavi Board of Directors agreed to fear that IPV would not be accepted in some communities, support the introduction of IPV in Gavi-eligible and Gavi- a large emphasis was placed on developing a strong graduating countries. It is important to note that Gavi’s support communication plan and messages. As explained by Dr. for IPV differs from their support for other vaccines (PCV, Emmanuel Abanida, Director of the Disease Control & penta, Rota, and HPV). For example, in order to be eligible Immunization team at the Ministry of Health Nigeria, “IPV is to apply for other vaccines, countries must have achieved a polio vaccine, and we know there has been problems with DTP3 coverage >70% and commit to co-financing the vaccine the polio vaccine before. The introduction process required introduction. However, in the case of IPV introduction, Gavi serious sensitization – serious sensitization. We needed to get waived the minimum coverage requirement and did not the buy-in of various stakeholders: traditional leaders, religious require countries to co-finance any part of the introduction. leaders, communities, ministries of health, NGOs, CSOs.”

Gavi’s special IPV policy had major implications for the In April 2014, community acceptability studies were introduction of IPV in Nigeria because without these conducted in four different states (Borno, Cross River, Kano, exceptions, Nigeria would not have been eligible to apply and Sokoto) by the USA Centers for Disease Control and for IPV support and would have had to self-finance IPV Prevention (US-CDC). Borno, Kano, Sokoto, and Cross River introduction. In this situation, the Government of Nigeria were chosen because they represented a high-risk security would have had to find alternative mechanisms to pay for state, a polio reservoir state, a state at high-risk for polio the cost of IPV. Gavi’s unique support for IPV was pivotal in importation, and a low-risk state respectively. pushing forward the national decision for introducing IPV. Findings from the acceptability studies showed that IPV was The New Vaccine Introduction (NVI) task team, which highly acceptable and its administration with OPV was perceived is comprised of representatives from Nigeria’s National to be beneficial to the child’s health. Despite these positive Primary Health Care Development Agency (NPHCDA) and views, concerns were raised about its side effects, safety, and immunization partners (WHO, UNICEF, the Bill & Melinda the need to continue OPV use. To address these concerns, Gates Foundation, the International Vaccine Access Center immunization managers and health officers were sensitized (IVAC), the US Centers for Disease Control and Prevention and trained on how to communicate with caregivers on the (CDC), and the Clinton Health Access Initiative (CHAI), was importance of vaccines, effects of polio and consequences responsible for compiling all the relevant documents that were of not taking IPV and OPV. In addition, the findings from the used by the Core Group and ICC for the decision making. acceptability studies were used to develop targeted messages for IPV introduction. The key messages were: (1) Give your child In March 2014, the ICC reviewed and endorsed the decision double protection today against Polio with IPV and OPV; (2) IPV to introduce IPV in Nigeria. The ICC decided that one for children 14 weeks of age. OPV for children from birth to 59 dose of IPV would be administered at 14 weeks of age, at months; and (3) Take your child to the nearest health center for the same immunization visit as OPV3, penta3, and PCV3. vaccination with IPV and OPV today! It is safe! It is effective! Following this decision, Nigeria submitted an application to Gavi requesting financial support to introduce IPV. In Preparation of Materials December 2014, Gavi approved Nigeria’s request for IPV Information, Education, and Communication (EIC) materials support and thereby agreed to provide funding for 6.8 million were developed for caregivers, while IPV training materials IPV doses and associated supplies each year from 2015- were developed for both facilitators and participants in May 2018 (approximately $12-14 million USD per year). Gavi 2014. Subsequently, follow-up meetings to finalize IPV also agreed to provide financial support for IPV introduction materials were held in December 2014. activities in the form of a Vaccine Introduction Grant (VIG) (approximately $5.8 million USD). The RI data tools (child immunization cards, immunization

14 | Case Studies of IPV Introductions: Albania, Nigeria, and Tunisia • 2015 registers, tally sheets, and summary forms, monthly vaccination At this time, it was decided that priority states that had performance chart, and vaccine management tools) were completed all preparatory activities (e.g. training, revised revised in June 2014 to include IPV; and immunization tools, etc.) would introduce IPV as soon as possible, while managers and officers were trained on how to use the tools to other states would wait to introduce until they were ready. capture IPV vaccination data. However, prior to the introduction, health workers were made to use the old tools, which made a There were fears that if the financial support was not provision for IPV before the distribution of the revised tools. provided on time, IPV introduction would be postponed again. To ensure successful IPV pre-introduction activities A cold chain readiness assessment (also known as an and to avoid postponements related to the delays in the effective vaccine management (EVM)) was conducted in receipt of VIG, the country made alternative plans to 2013. The assessment revealed that Nigeria had adequate provide funds for programmatic activities needed for IPV storage capacity to include IPV. The recent expansion of the introduction. UNICEF served as a fiduciary agent responsible cold storage capacity to accommodate PCV and Rotavirus for managing the VIG for IPV introduction and also offered vaccine was 40% more than what was needed for IPV across to pre-finance some activities including the development all levels. In-country development partners such as CHAI also of IEC materials for the vaccine introduction pending the provided analytical support to NPHCDA and UNICEF on the receipt of VIG. CHAI provided supplementary resources cold chain inventory update. to support pre-introduction activities such as funding for the development of IPV training manuals, nationwide IPV Accelerated Ipv Introduction In High-Risk States stakeholder sensitization meeting, and support for NPHCDA An accelerated vaccine introduction was conducted in June staff to monitor state level training. UNICEF and CHAI 2014 in the 3 high-risk states (Borno, Yobe and Kano) with provided these funds because the delivery of the VIG from funding from the Bill and Melinda Gates Foundation. This Gavi was yet again delayed. was driven by the need to quicken the timeline for polio interruption starting in the most security compromised states Training and underserved populations. Lessons learned from the On 14 January 2015, a national meeting was held to limited introduction were used to improve planning strategies inform key stakeholders (state-level decision makers, for training, community mobilization, and communication for state-level immunization technical officers, the Nigerian the nationwide rollout of IPV. Pediatric and Medical Associations, and partner organizations) about IPV introduction. At this meeting, Timeline For Introduction NPHCDA and in-country development partners presented Although the national introduction of IPV into routine and discussed the country’s plan for IPV introduction. immunization was originally planned for 1 December 2014, Other highlights of the discussion included sharing the the introduction was delayed due to: (1) global shortage of progress and challenges of immunization in Nigeria, IPV, (2) inadequate human capacity at the Local Government major findings from the community acceptability studies Area (LGA) and health facility levels, (3) competing priorities, on IPV and identifying state specific challenges with IPV and (4) logistics challenges at the federal level. IPV introduction. introduction was rescheduled for early 2015. It was decided that instead of a single nationwide introduction, IPV would On 19 January 2015, immunization managers and officers be introduced through a phased strategy. In this strategy, were trained by NPHCDA and in-country development IPV would be launched in the Federal Capital Territory (FCT), partners on how to use the training manuals (both the which includes the capital Abuja, and several priority states facilitators’ guide and healthcare worker manuals). This (i.e. high-risk states in the north-east and north-west) on the training also included a session on effective communication 11th of February 2015. All remaining states would introduce on IPV, which focused on the importance of vaccination and on the 16th of March 2015. the consequences of non-compliance. Finally, participants were trained on safe administration and storage of IPV as However, at beginning of 2015, a decision was taken to well as adequate reporting of adverse events. During the further delay IPV introduction because the Gavi decision training, the participants had an opportunity to voice what letter was delayed and the VIG funds were still not available. they perceived would be the key challenges facing IPV Consequently, most state level trainings were postponed introduction in their individual states. until the VIG funds arrived. Only priority states conducted trainings. Additionally, only a limited number of training On 27th of February 2015, UNICEF received the VIG for manuals were produced leading to the unavailability of IPV introduction in Nigeria. Following the receipt of the manuals in some states, and the revised immunization tools grant, other remaining states commenced pre-introduction were still not available at the LGA level. activities.

International Vaccine Access Center (IVAC) • Johns Hopkins Bloomberg School of Public Health | 15 IMPLEMENTATION time from the national decision to introduce IPV (March 2014) to the national launch ceremony (February 2015) Two states (Jigawa and Bauchi) introduced IPV on 11th was very short (11 months). Multiple factors enabled this and 12th of February 2015, respectively. A national launch condensed timeline including: (1) a strong global WHO ceremony was held in Abuja on the 20th of February recommendation for the rapid introduction of IPV, (2) Gavi 2015. As of June 2015, 28 of 36 states plus the FCT have did not require co-financing for IPV, (3) technical assistance introduced IPV, leaving 9 states still to introduce. was provided to help develop the IPV introduction plan and Gavi application, (4) stakeholders were able to use their A single dose of IPV is administered at 14 weeks to children experience from two recent new vaccine introductions (PCV less than one year of age. According to the country’s and penta) to help the planning process, and (5) partners immunization schedule, this dose is administered along with were determined to overcome obstacles (e.g. determination OPV3, penta3 and PCV3. In terms of eligibility, children who to overcome the obstacles presented by the health worker have received their penta3 but are less than 1 year at the date strike in Nigeria by sending letter from the RIWG to the of IPV introduction are eligible for IPV vaccination. In contrast, Union of Healthcare workers requesting permission to have children older than one year by the date of IPV introduction workers break ranks in order to attend IPV trainings, partners are NOT eligible for IPV vaccination. This eligibility policy is provided supplementary funding from UNICEF and CHAI practical and in-line with supply and cost consideration, in when Gavi funds were delayed, etc.). As stated by Dr. Pascal order to improve stock management and minimize stock-outs. Mkanda, Team Leader for Immunization at WHO Nigeria, “I think the important lesson is consensus from the beginning. The country made the decision to introduce the WHO It was very important that everybody was brought along from prequalified 5-dose stand-alone presentation of IPV. This dose the beginning.” was chosen because it strikes a balance between reducing cost/ wastage and optimizing storage capacity (the benefits of the Lesson 2—Shortened timelines have disadvantages cost-savings of 5-dose vial outweighs the benefits of the small While the introduction of IPV was rapid, the condensed saving in space from the 10-dose vial). In addition, the multi- timelines came with some disadvantages. During preparation dose vial policy (MDVP) followed at the time of introduction was it became clear that the original timeline did not allow that the 5-dose vial introduced MUST be discarded at the end of enough time for preparation activities (trainings and revising the immunization session or within six hours of being opened, as materials). As a result, Nigeria had to transition from a single recommended by WHO until vial could be received with vaccine nationwide introduction to a phased introduction in order to vial monitors (VVMs) on the label.11 Health workers were trained introduce IPV in some select areas by early 2015. on the current multi-dose vial policy with the understanding that refreshed training would be needed when new vials were Lesson 3—Training manuals were found to be a better way received. The new policy enables vials that met certain criteria to to maintain consistency in training content in contrast to be discarded after 28 days to reduce wastage. PowerPoint Presentations During PCV training, trainers found that it was challenging In states that have already introduced IPV, preliminary findings to maintain consistency in trainings at the state and local suggest that IPV has been well accepted. Healthcare workers level. To mitigate this challenge, a more effective training attributed their acceptance of IPV to the fact that IPV is delivery approach was used for IPV. This approach utilized administered by a trained health worker (which is in contrast to printed training manuals instead of the usual PowerPoint OPV that does not require a skilled worker for its administration). presentations, in order to maintain consistency at the There were no perceived concerns around multiple injections different levels’ trainings. as injectable vaccines were seen to be effective. However, there were worries surrounding the side effects of IPV. Lesson 4—The program should engage stakeholders at the state and Local Government Area (LGA) level to improve LESSONS LEARNED planning It is critical to engage stakeholders at the state and LGA level Lesson 1—It is possible to introduce a vaccine rapidly if there to help improve the planning process at these levels. For is consensus among all stakeholders IPV, activities were conducted at the national level, but fewer Compared to previous vaccine introductions in Nigeria, the activities were conducted at the state and LGA level.

Lesson 5—In-country immunization partners were 11 Application of WHO Multi-Dose Vial Policy for Inactivated Polio Vaccine. instrumental in IPV introduction November 2014. Available at: http://www.who.int/immunization/diseases/ poliomyelitis/inactivated_polio_vaccine/MDVP_Nov2014.pdf (accessed 11 Many different organizations were involved in supporting August 2015) IPV introduction: (1) the Gates Foundation funded the

16 | Case Studies of IPV Introductions: Albania, Nigeria, and Tunisia • 2015 accelerated limited introduction of IPV in three high risk Lesson 7—Sustainable financing mechanisms must be polio states, (2) the CDC helped conduct the community developed for future vaccine introductions acceptability study for IPV prior to introduction, (3) CHAI The majority of delays in IPV introduction were a result of provided analytical support for the cold chain inventory the delay in the delivery of the vaccine introduction grant update and supplementary funding for IPV introduction from Gavi. This underlines the disadvantages of relying on activities, (4) IVAC helped facilitate the state level training, (5) donors to fund programmatic activities and highlights the UNICEF served as a fiduciary agent responsible for managing benefits of self-financing programmatic activities. Relying the VIG for IPV introduction and also offered to pre-finance on donors for essential activities (sensitizations, training, some activities for the vaccine introduction pending the and material development) creates dependence and can receipt of VIG, and (6) WHO oversaw the development of result in delays. Considering that Nigeria will be graduating IPV introduction guideline, provided technical assistance to from Gavi support in the coming year, the program needs NPHCDA, and aided in capacity building trainings for the to identity and secure reliable resources to fund program- vaccine introduction. related costs.

Lesson 6—Last-minute financial support from partner Lesson 8—Compared to other vaccines, communication organizations was needed to provide immediate relief after about IPV was crucial because there is less demand for polio delays in the Vaccine Introduction Grant vaccines Because the disbursement of the Vaccine Introduction Grant As explained by Dr. Emmanuel Abanida, Director of the from Gavi was delayed, as of December 2014, there was Disease Control & Immunization team at the NPHCDA, still no funding available to conduct a variety of essential “The difference between penta and IPV is that penta is felt preparation activities. This led to the fear that the introduction to be a “needed” vaccine. Nobody wants a child to die of of IPV would be delayed a third time. However, two partner meningitis or pertussis. So it is not difficult for people to organizations (UNICEF and CHAI) stepped in and provided accept penta. But IPV is a polio vaccine, and so we needed funding to cover programmatic activities while the government to convince people that this polio vaccine is supposed to help waited for the arrival of the Vaccine Introduction Grant (VIG). us to quickly end polio. So the need for the advocacy was This allowed the introduction to move forward as planned. stronger. The need to build trust was stronger. The need to be Other countries should be aware of the potential delays in the transparent was stronger.” This underscores the need to build arrival of the VIG and should arrange a back-up plan in case strong communications plans particularly in countries with a this happens again. lot of polio activity.

TIMELINE November 2012: SAGE recommendation for all countries to introduce at least 1 dose of IPV September 2013: African Regional Committee discusses IPV introduction February 2014: Technical assistance provided to develop IPV introduction Plan and Gavi Application March 2014: Nigeria ICC recommends IPV introduction March 2014: Government of Nigeria submits application to Gavi April 2014: IPV acceptability studies conducted in partnership with CDC May 2014: National level training materials developed June 2014: An accelerated IPV introduction was conducted in select northern states October 2014: Gavi conditionally approves IPV application December 2014: National level training materials developed December 2014: Gavi approves IPV introduction January 2015: UNICEF pre-finances some IPV introduction activities pending the receipt of the VIG January 2015: CHAI provides supplementary funding to support introduction activities January 2015: National sensitization meeting and state level training conducted February 2015: Jigawa and Bauchi state introduce IPV on 11th and 12th of February February 2015: Abuja hosts national launch ceremony for IPV on 20th of February 2015 February 2015: Vaccine introduction grant arrived in country on 27th February 2015 March-June 2015: An additional 25 states introduce IPV

International Vaccine Access Center (IVAC) • Johns Hopkins Bloomberg School of Public Health | 17 TUNISIA 18 | Case Studies of IPV Introductions: Albania, Nigeria, and Tunisia • 2015 TUNISIA

INTRODUCTION DECISION-MAKING

Tunisia is a country located in North Africa and borders Libya, The national Vaccine Technical Committee (CTV) is the Algeria, and the Mediterranean Sea. It has an estimated main decision-making body for immunization policies and population of about 11.2 million and an annual birth cohort of recommendations in Tunisia. approximately 190,000.12 It is classified by the World Bank as an upper-middle income country.13 The membership of the CTV is multi-disciplinary and consists of experts in relevant medical disciplines (virology, pediatrics, Tunisia has a strong immunization program, with routine infectious disease, and epidemiology), representatives from immunization coverage estimated to be 98% for DTP3 the regulatory authorities, government entities including (2013).14 Tunisia is not eligible and has never been eligible for the Director of the Primary Care Division of the Ministry financial support from Gavi. As a result, the Government has of Health (DSSB) and the National Vaccination Program self-financed every new vaccine introduction. Since 2000, Manager, and other individuals as needed. The CTV makes Tunisia has added vaccines against two additional antigens all initial recommendations regarding vaccinations. After the to the immunization schedule: Haemophilus influenzae committee makes a new vaccine recommendation, the DSSB type b (Hib) and rubella. The Hib vaccine was originally develops a budget and product specifications for the vaccine. introduced in October 2002 as a standalone vaccine. In Next, the Ministry of Health requests a budget allocation early 2006, due to the high cost of the vaccine and limited from the Ministry of Finance to cover the cost of the vaccine. financial resources, the Hib vaccine was removed from the It is also important to note that unlike some middle-income national immunization program. Evidence from the Children’s countries, Tunisia procures vaccine independently and not Hospital of Tunis showed that the removal of the vaccine was through the UNICEF Supply Division. For each vaccine in the followed by a resurgence of Hib meningitis cases, justifying national immunization program, the government submits a its re-introduction. In 2011, the Hib vaccine was reinstated in public tender, negotiates a price, and purchases the vaccine the form of the pentavalent vaccine (DTwP-HepB-Hib). The without support from external partners. rubella vaccine was introduced in 2005 as a combination Vaccine introductions in Tunisia: Measles-Rubella (MR) vaccine that replaced the stand-alone measles vaccine. Year Vaccine Financing 2002 Hib Government Although endemic wild poliovirus transmission was 2005 Rubella (as MR) Government interrupted in Tunisia in 1992, Tunisia is geographically 2006 Hib removed Government 2011 Hib (as Penta) Government located in the same region as two polio endemic countries— 2014 IPV Government Afghanistan and Pakistan. Due to the geographic location, it is possible that a poliovirus could be imported into Tunisia. In 2012, the National Vaccination Program of Tunisia Maintaining high population immunity against polio through drafted a Five-Year Plan (Plan Quinquennal). Among other immunization is crucial in order to prevent an outbreak. things, this plan indicated that IPV would be introduced The risk of a polio importation has been demonstrated in in 2014. However, by mid-2013, there was still no formal other countries in the region including the outbreak in Syria recommendation or plan for IPV introduction. in 2013, the detection of polio in the sewage in Egypt, and the prolonged silent circulation of wild poliovirus in Israel. During the CTV meeting on 13 December 2013, the CTV of For this reason, the government of Tunisia is committed to Tunisia discussed the introduction of IPV. At this meeting, maintaining high vaccination coverage for polio and strong the committee decided that IPV introduction would only surveillance for polioviruses. become a priority of the immunization program if there were supply problems with OPV. Subsequently, during the second half of 2013, Tunisia experienced two major 12 United Nations, Department of Economic and Social Affairs, Population Division (2013). World Population Prospects: The 2012 Revision, CD-ROM problems with OPV supply. First, the Ministry of Health Edition. received a shipment of 20-dose vials instead of 10-dose 13 World Bank, country and lending groups, 2014 revision. Updated vials as requested. Second, only one supplier indicated annually in July. Available at: http://data.worldbank.org/about/ intent to respond to the upcoming OPV tender, which country-and-lending-groups meant Tunisia had no choice of suppliers. Following these 14 WHO-UNICEF estimates of DTP3 coverage, 2014 revision. Updated annually in July and available at: http://apps.who.int/immunization_ issues with the supply of OPV, in December 2013, the CTV monitoring/globalsummary/timeseries/tswucoveragedtp3.html made a formal recommendation to introduce IPV in order

International Vaccine Access Center (IVAC) • Johns Hopkins Bloomberg School of Public Health | 19 to ensure that polio immunity in the country would remain national immunization mangers were sensitized on IPV. The strong despite OPV supply issues. As stated by Dr. Nabil National Managers then trained regional staff at a “training Ben Salah, Director General of Health, Tunisia, “Polio is a of trainers” meetings. From June-July 2014, the regional disease that is practically eliminated from Tunisia, but we trainers trained the vaccinators. Prior to introduction, radio have to acknowledge that there is a possibility that it could spots were produced and a press release was created by come back. So the objective in introducing IPV is to achieve the DSSB to advertise IPV. the complete eradication of polio, which means avoiding even one new case. For us, Tunisia, the elimination of IMPLEMENTATION polio has been a great success and we want to prevent any re-emergence of the disease.” IPV was originally planned to be introduced in July 2014, but it was delayed until September 2014. IPV introduction After deciding to introduce IPV, Tunisia had to decide: (1) was postponed by two months because it took longer than how many doses of IPV would be administered and (2) at anticipated to train all of the healthcare personnel involved which age children would receive the IPV dose(s). in the introduction. This was mostly a result of training being originally scheduled during times that overlapped Following the recommendation for IPV, in February 2014, with summer vacation and Ramadan (June 28-July 28). the National Vaccination Program (PNV) submitted a budget Otherwise, the introduction went according to the original request to the Ministry of Finance requesting funds to support planned timelines. the introduction of IPV. Recognizing the difficulty in mobilizing enough funding to support two doses of IPV within the short In Tunisia, the National Healthcare Booklets were revised time frame, the national immunization program decided to and disseminated prior to IPV introduction. The Regional introduce one dose of IPV in September 2014 with the intent Report of Vaccination Program Activities was also amended of introducing a second dose of IPV in January 2016 when to include IPV, so that IPV administration in clinics could be additional funding could be made available. tracked at the regional level. However, the vaccine registers used at each clinic to record which vaccines each child Regarding the timing of the IPV dose, the initial received were not amended prior to introduction. As a recommendation made by the CTV in December 2013 solution, the nurse/vaccinator used the area previously used was to replace the first dose of OPV (given at two months for OPV to record that the child received both IPV and OPV at in Tunisia) with a dose of IPV, and then replace all doses 6 months. of OPV with IPV over time. However, because of the SAGE recommendation, which stated that (1) IPV should be Preliminary findings have shown that the acceptability of given in addition to OPV and (2) that the dose should IPV among healthcare professionals and caregivers is high. be given at or after 14 weeks—in March 2014 the CTV One reason cited for strong acceptance is the overall trust revisited their original recommendation. Currently, OPV of the public in the immunization program. It should also is administered at 2 months, 3 months, and 6 months be recognized that IPV has been used in the private sector of age. Some committee members argued that the dose as part of the hexavalent vaccine. The availability of IPV should be given at 6 months of age in order to optimize in the private sector has meant that Tunisian healthcare seroconversion of infants against type-2 polio. Others personnel—as well as the average citizen—were aware of wanted to introduce IPV at 2 months of age, particularly IPV and its use. This established familiarity with IPV made after examining Tunisian VAPP data, which suggested both public sector healthcare personnel training and parental that VAPP in Tunisia tended to occur following the first education significantly easier. dose of OPV. Ultimately, the committee decided that one dose of IPV at 6 months of age would be most LESSONS LEARNED appropriate, given that VAPP was very rare in Tunisia and that there was a large benefit to waiting until 6 months to Lesson 1—Rapid introduction is possible in a strong routine administer IPV. immunization program One of the most remarkable aspects of IPV introduction PRE-INTRODUCTION ACITIVITES in Tunisia was the speed with which it was executed. In total, there were nine months between the initial decision In March 2014, Tunisia began preparing for IPV to introduce (December 2013) to the actual introduction introduction. The national immunization program revised (September 2014). A key factor that enabled this rapid the National Health Booklets and the national vaccine introduction was the strength of the existing routine database to include IPV. In April, technical training immunization program in Tunisia. The strong routine documents were created for healthcare workers. Next, the program provided a solid base that made introducing a new

20 | Case Studies of IPV Introductions: Albania, Nigeria, and Tunisia • 2015 vaccine relatively simple. This underscores the importance this vaccine would prevent a higher level of mortality and of continued efforts to strengthen the routine immunization morbidity. At more than twice the Tunisian budget, the program. pneumococcal conjugate vaccine was considered too expensive given that the IPV vaccine needed to be prioritized. Lesson 2—General public demand for immunization enabled smoother introduction of IPV Lesson 6—A standardized and centralized decision-making IPV was widely accepted by caregivers and the public process was important for IPV introduction in Tunisia. As described by Professor Souad Bousnina, National Immunization Technical Advisory Groups (NITAGs) President of the Vaccine Technical Committee, “Vaccination are multidisciplinary groups of experts responsible for is very well established in our country. Parents already view it providing independent, evidence-informed advice to as a necessity. So when we make a change from one vaccine governments on vaccine policy-related issues. In Tunisia, to another that is supposed to be better, it’s something that the National Vaccine Technical Committee (CTV) is the is very well accepted by parents, by vaccinators, and by NITAG equivalent that meets quarterly to discuss all things doctors.” related to vaccine policy. In regards to IPV introduction, the existence of a functional NITAG with centralized Lesson 3—A political and historical legacy of commitment to decision-making power allowed the government to take vaccination contributed to the high acceptance of IPV swift action regarding IPV introduction. Once the CTV Following independence, the Government of Tunisia placed recommended IPV introduction, the national immunization a high priority on health and education. This has resulted in program immediately began preparation for the nationwide a historical legacy of political commitment to immunization. introduction of the vaccine. This experience underscores Tunisians take pride in the national immunization program the benefits of having a functional NITAG that can translate and see the program as one of the major successes of global recommendations on immunization into national Tunisia. As eloquently described by Dr. Nabil Ben Salah, policies. Director General of Health, Tunisia, “Since its independence in 1956, Tunisia has been seriously committed to health and Lesson 7—The availability of data and a strong NITAG can education. Consequently, vaccines have been introduced lead to evidence-based decisions very quickly in our country and Tunisians are able to adapt The availability of VAPP data in Tunisia in addition to a very quickly to new vaccines. Now, the average Tunisian fully functional NITAG ensured that the decision for the demands vaccines. This has meant that introducing a new new polio immunization schedule was evidence-based and vaccine, even an injectable vaccine, is not problematic. On tailored to Tunisia’s needs. Before making a decision, the the contrary, it is something that the average Tunisian citizen CTV had an important debate about the advantages and finds reassuring.” disadvantages of the different dosing schedules. Because the NITAG was comprised of a diverse set of stakeholders Lesson 4—OPV supply issues accelerated the decision to (national, regional, programmatic, scientific), they were introduce IPV able to consider all aspects of IPV introduction when Due to OPV supply concerns in 2013, the vaccine supply making a decision. Following the discussion, the CTV committee recommended the introduction of IPV in 2014. chose the schedule that they felt was the best fit for the Because there was concern about the future supply of OPV Tunisian context. One dose of IPV would be introduced and because IPV had previously been included in the original in 2014 at 6 months (to ensure strong immunity) and in Five Year Immunization Plan, Tunisia was able to accelerate 2016 a second dose of IPV would be added at 2 months the decision to introduce IPV. (to prevent VAPP).

Lesson 5—Limited resources meant that trade-offs had to be Lesson 8—The availability of certain vaccines in the private made for IPV and other new vaccine decisions sector can influence local perceptions Despite a desire to introduce two doses of IPV, the CTV In Tunisia, IPV has been available for purchase in the private recommended that initially a single dose of IPV at 6 months sector for many years. As a result, many caregivers were of age should be introduced because of difficulties in familiar with IPV and saw it as a safe and effective vaccine. rapidly mobilizing funds to pay for both doses. The CTV In Tunisia, this contributed to the overall positive perception recommended that resources could be secured for a of IPV and is cited as another factor in its high acceptance second dose of IPV, which would be added to the national among caregivers. However, national immunization programs immunization schedule at 2 months to eliminate the rare risk should be aware that the availability of certain vaccines of VAPP. The second implication of limited resources was in the private sector and how this can influence local that the CTV did not decide to introduce the pneumococcal perceptions of a vaccine (positive and negative). Additionally, conjugate vaccine (PCV) in 2014 despite the fact that it should be noted that the immunization schedule and

International Vaccine Access Center (IVAC) • Johns Hopkins Bloomberg School of Public Health | 21 vaccine formulations available in the private sector are often Health budgets are often set years in advance. This can be a different from those available in the public sector. In some big hurdle during the rapid introduction of a vaccine. In the circumstances, this can contribute to confusion among case of IPV in Tunisia, the national immunization program healthcare workers and parents. Programs should be aware was able to rapidly mobilize enough funding for a single of this and be prepared to manage the confusion. dose of IPV in 2014, but it should be noted that it was not possible to secure enough funding for two doses of IPV. For Lesson 9—It is difficult to mobilize funding when financial this reason, Tunisia decided to wait until 2016 to introduce a budgets have already been set years in advance second dose of IPV.

TIMELINE April 2012: Drafted Five-Year immunization plan with intention to introduce IPV in 2014 December 2013: Vaccine Technical Committee recommends IPV to be introduced January 2014: WHO/UNICEF joint letter to the Minister of Health encouraging IPV introduction February 2014: Ministry of Finance approves funding for 1 dose of IPV to be introduced March 2014: Vaccine Technical Committee (CTV) decides IPV will be given to children at 6 months of age March 2014: Order placed for IPV vaccine March 2014: Revised hard copy documents and national vaccine database April 2014: Creation of training materials and communication of new immunization schedule June 2014: Dissemination of the IPV introduction memo June 2014: Delivery of the vaccine and new hard copy materials June-August 2014: Training of managers, regional trainers, and vaccinators September 2014: IPV introduced into routine immunization

22 | Case Studies of IPV Introductions: Albania, Nigeria, and Tunisia • 2015 International Vaccine Access Center (IVAC) • Johns Hopkins Bloomberg School of Public Health | 23 International Vaccine Access Center (IVAC) Johns Hopkins Bloomberg School of Public Health 415 N. Washington Street, Floor 5 Baltimore, MD 21231 www.jhsph.edu/ivac